This Funding Opportunity Announcement (FOA) is being
issued to announce the availability of an estimated 12-15 cooperative
agreements to be awarded under a Limited Competition for the Tobacco
Regulation Awareness, Communication, and Education Program.

The purpose of the Tobacco Regulation Awareness,
Communication, and Education Program is to assist entities to establish or
expand health education and communication programs at the community level congruent
with the Tobacco Control Act.

The Program will advance public health by supporting community-based
programs that work to identify and disseminate evidence-based,
community-level best practices and improving access to standardized,
community-level data.

Strong applications will seek to educate and communicate to
1) promote the understanding of the consequences of tobacco use through
individual and community actions; 2) protect youth from the dangers of
tobacco use; and 3) increase cessation among those who use tobacco products. Funding
recipients must implement a comprehensive public education and/or
communication program that addresses federal tobacco regulations and the
public health goals which flow directly from them, as identified in the
applicant’s needs assessment and that will improve health outcomes for
members of target population(s).

Key Dates

Posted Date

March 15, 2012

Open Date (Earliest Submission Date)

March 15, 2012

Letter of Intent Due Date

April 9, 2012

Application Due Date(s)

May 9, 2012 by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2012

Advisory Council Review

September, 2012

Earliest Start Date(s)

September, 2012

Expiration Date

May 10, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF 424 (R&R) Application Guide except where instructed to do otherwise
in this FOA. Conformance to all requirements (both in the Application
Guide and the FOA) is required and strictly enforced. Applicants must read and
follow all application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the Application
Guide, follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

The Tobacco Regulation Awareness, Communication, and
Education Program is authorized by 42 USC 300u-3 of the Public Health Service
Act and the Family Smoking Prevention and Tobacco Control Act (PL 111-31).

PROGRAM
BACKGROUND

Tobacco use is the foremost preventable cause of premature
death in America. It causes over 400,000 deaths in the United States each year, and approximately 8.6 million Americans have chronic illnesses related to
smoking.
A compelling body of evidence illustrates that tobacco products
are inherently dangerous and cause cancer, heart disease, and other serious
adverse health effects.

On June 22, 2009, President Obama signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act), P.L. 111-31, giving
the Food and Drug Administration (FDA) regulatory authority over tobacco
products.

The Tobacco Control Act is a Federal law that gives FDA the authority
to regulate the manufacturing, labeling, sale, distribution, advertising and promotion
of tobacco products. The Tobacco Control Act recognizes that virtually all new
users of tobacco products are under 18 – the minimum legal age to purchase
these products. Many new users will become addicted before they are old
enough to understand the risks and ultimately will die too young of
tobacco-related diseases. Among other central goals, the Tobacco Control Act
seeks to prevent and reduce tobacco use by these young people.

Some key FDA activities authorized or required by the Tobacco
Control Act include:

Mandating larger, more varied, and more prominent warning labels
on cigarette and smokeless tobacco products (Title II of the Tobacco Control Act)

Restricting tobacco product advertising and promotion (Sec.
906(d) of the of the Federal Food, Drug, and Cosmetic Act (FD&C Act);
section 102 of the Tobacco Control Act)

Prohibiting explicit and implicit claims of modified risk or
modified exposure (including “light,” “low,” or “mild” and similar
descriptors), without an FDA order that the modified risk product may be marketed
(Sec. 911 of the FD&C Act)

In general, allowing the introduction of new tobacco products to
those that FDA determines are "appropriate for the protection of the
public health." (Secs. 905, 910 of the FD&C Act)

Collecting data on certain tobacco product constituents,
ingredients, and additives and establishing a list of harmful and potentially
harmful constituents in tobacco products, including smoke constituents, by
brand and subbrand (Sec. 904 and 915 of the FD&C Act)

Please visit www.fda.gov/tobacco for more information on the Tobacco Control Act and related regulations,
guidance, and other educational information.

To implement the new law, Congress directed the creation of
the Center for Tobacco Products (CTP) at FDA. CTP’s mission is to protect
Americans from tobacco-related death and disease by regulating the manufacture,
distribution, and marketing of tobacco products and by educating the public,
especially young people, about tobacco products and the dangers their use poses
to themselves and others.

As noted in FDA’s Strategic Priorities for 2011-2015 (see Food and Drug Administration
Strategic Priorities 2011-2015: Responding to the Public Health Challenge of
the 21st Century), CTP’s mission focuses on two overarching
priorities that support protection of the public’s health: tobacco regulation
and communication/public education. CTP’s long-term public health outcomes
include:

Reducing the number of deaths and diseases associated with the
use of tobacco products, and

Reducing the number of youth using tobacco products in the United States.

CTP seeks to catalyze these outcomes, rooted in the Tobacco
Control Act, through regulation, communication, and public education
particularly as it pertains to: (1) promoting public understanding of tobacco
products and risks associated with tobacco product use (including health and
dependency effects, impacts of tobacco product ingredients and additives; and
the life threatening health consequence of tobacco use); (2) reducing tobacco
use among minors, which would prevent significant numbers of today’s children
from becoming regular, daily tobacco product users, saving them from premature
death due to tobacco-induced disease, and (3) increasing cessation among
current (primary adult) tobacco product users.

OVERARCHING
PROGRAM GOAL

The goal of the Tobacco Regulation Awareness, Communication,
and Education Program is to educate Americans about the risks of tobacco
products. It seeks to increase capacity at the community level in the areas of
health communication and education that address federal tobacco regulations and
the public health goals of the Tobacco Control Act. The Program will help
increase knowledge and encourage long term behavior change which will
contribute to reductions in the morbidity and mortality associated with tobacco
use in the U.S.

As highlighted above, these efforts are rooted in the
Tobacco Control Act and in regulations CTP has and plans to issue. For these
measures, from the restrictions on the use of light, low, and mild descriptors
to graphic health warnings, it is important that the public health intent be
communicated to the public. This Program will help do that in local communities
across the nation, catalyzing and learning from best practices, and
complementing CTP’s regulatory and national health education and communication
efforts.

Although FDA-centric, this Program involves extensive
coordination with related Federal grant and cooperative agreement programs,
like those administered by the Centers for Disease Control and Prevention, to
create synergy and avoid duplication.

PROGRAM
PURPOSE

The purpose of the Tobacco Regulation Awareness,
Communication, and Education Program is to assist entities to establish or
expand health education and communication programs at the community level
congruent with current and future FDA tobacco regulation.

The Program will advance public health by supporting
community-based programs that work to identify and disseminate evidence-based,
community-level best practices and improving access to standardized,
community-level data.

PROGRAM
PRIORITIES

The Program’s grant funds would support eligible entities in
carrying out their plans to establish or expand health communication and
education programs congruent with the Tobacco Control Act. Strong applications
will seek to educate and communicate to:

Promote the understanding of the consequences of tobacco use
through individual and community actions;

Protect youth from the dangers of tobacco use; and

Increase cessation among those who use tobacco products.

The public education and/or communication program must
include the following activities:

1)
Propose a communication/education project that is evidence-based and
relies on:

Previous work in the area of tobacco regulation, prevention,
and/or cessation; or

Promising or innovative communication/education strategies to
advance the public's health consistent with federal tobacco regulation and the
public health goals of the Tobacco Control Act.

2)
Demonstrate at least one collaboration between a governmental agency and
a community-based partner to identify and implement innovative strategies to
help reduce the harms caused by tobacco use and help strengthen and/or sustain
new or existing health communication and education infrastructures in the
community.

3)
Plan, build, adapt, or expand data collection, management, and reporting
protocols for program activities. This data will be used by the funding
recipient for program monitoring, continuous program improvements, and
accountability.

4)
Evaluate program processes and outcomes, including formative and
summative evaluation, to document and disseminate results and outcomes.

Each applicant must propose to address at least one or more
of the following audiences:

Tweens (Ages 8-12);

Teens (Ages 13-17);

Young Adults (Ages 18-24);

Adults (Ages 25-44) with Kids;

Targeted, vulnerable, and/or minority populations, e.g. pregnant
women, those that are hard to reach and are identified as such in the needs
assessment.

Program activities and strategies must be based on a needs
assessment, a gap analysis based on what other tobacco control programs are
doing, and science-based results and recommendations from published research
synthesis and/or meta analyses, such as those outlined in the U.S. Community
Guide for Preventive Services (see http://thecommunityguide.org/tobacco/index.html).

Applicants must propose innovative, evidence-based, and
collaborative programs that educate the public, especially young people, about
tobacco products and the dangers their use poses to themselves and others.
Applicants should tailor their strategies to meet the unique needs of local
target audiences by identifying and implementing novel ways for community
stakeholders to reach audiences in their communities. Additionally, applicants
must demonstrate how proposed activities are related to CTP’s regulation of
tobacco products under the Tobacco Control Act.

By way of example, project activities could include:

a) Applicants and community stakeholders identifying and
implementing novel approaches to improving public health by educating target
audiences about FDA's authority to publish a list of harmful and potentially
harmful constituents in a format that is understandable and not misleading to
the public. Examples include:

i. Identifying and implementing novel ways for community
stakeholders to take the information published by the FDA for every tobacco
product brand and effectively reach youth in their communities with a message
about the harmful and potentially harmful constituents in tobacco products to
prevent initiation, while working with FDA to ensure the information being made
available is understandable and not misleading to the audience.

ii. Identifying and implementing ways for community
stakeholders to involve tobacco influencers such as parents and caregivers in
educating youth about the harmful and potentially harmful constituents in
tobacco products to impact behavior, while working with FDA to ensure the
information being made available is understandable and not misleading to the
audience.

b) Applicants and community stakeholders identifying and
implementing novel approaches to provide accurate information to promote
awareness to the local community of the risks of smokeless tobacco. Examples
include:

i. Identifying and implementing novel ways for community
stakeholders to utilize required smokeless tobacco warnings, e.g.
"Warning: Smokeless tobacco is addictive." and effectively reach
youth in their communities about the dangers of using smokeless tobacco to
prevent initiation.

Note to Applicants:

Please be familiar with the specific provisions of the
Tobacco Control Act and the regulatory activities of FDA. In addition to
demonstrating how the proposed project is related to CTP’s regulation of
tobacco products under the Tobacco Control Act, applicants must demonstrate how
it will advance the pubic health goals that underlie these FDA activities.
Please visit www.fda.gov/tobacco for
more information on the Tobacco Control Act and related regulations, guidance,
and other educational information.

Please note that funds may not be used towards tobacco
control compliance and enforcement efforts. Program funds may not be used to
duplicate or supplant existing tobacco control, prevention, or cessation efforts,
but can enhance existing communication/education efforts relevant to FDA/CTP
and the Tobacco Control Act. Funds may not be used to fund other tobacco
control areas such as surveillance, price and tax measures, clean indoor air
laws, tobacco control compliance and enforcement efforts, and treatment
services like quit lines, nicotine replacement therapy, or any other
pharmaceutical or biomedical therapy.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, FDA scientific or program
staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New: Refers to an application not previously proposed, or
one that has not received prior funding. Also known as a Type 1.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA/CTP
appropriations, and the submission of a sufficient number of meritorious
applications.

FDA/CTP intends to fund approximately 12-15 awards,
corresponding to a total of $22,500,000 depending on the availability of
funds.

Fiscal Year Funds: 2012

Estimated Current Fiscal Year (FY) Funding: $22,500,000

Estimated Current Fiscal Year Range of Awards: up to $1,500,000

Maximum Size Award in Current Fiscal Year: $1,500,000

Estimated Number of Awards: 12-15

FDA/CTP anticipates that project costs may escalate in
future funding years as project activities transition from an emphasis on
project start up in FY 2012 to project implementation in FY 2013, FY 2014,
and FY 2015.

Estimated Future Year Funding:

FY 2013 ($45,000,000)

FY 2014 ($45,000,000)

FY 2015 ($45,000,000)

Estimated Future Year Range of Awards:

FY 2013 (up to $3,000,000)

FY 2014 (up to $3,000,000)

FY 2015 (up to $3,000,000)

Maximum Size Award in Future Years:

FY 2013 ($3,000,000)

FY 2014 ($3,000,000)

FY 2015 ($3,000,000)

Maximum Project Period: Four (4) Years

Award Budget

Awards are contingent upon the availability of funds.
Future year amounts will depend on annual appropriations and performance.

FDA/CTP anticipates that project costs will escalate in
future funding years as project activities transition from an emphasis on
project start up in FY 2012 to project implementation in FY 2013, FY 2014,
and FY 2015. Applicants should submit a detailed budget breakdown for each
budget category listed in the Budget Component form and a detailed budget
narrative justification for each year of financial support requested. The
budget should include only costs that are allowable, reasonable, and
necessary for carrying out the objectives of the proposed project.

The total amount of funding available in Fiscal Year 2012
is $22.5 million. It is estimated that up to 15 cooperative agreements will
be awarded, but not exceed $1,500,000 per award in total (direct plus
indirect) costs in FY 2012. The FY 2012 budget period will include an
initial 5 month planning period to support project start-up,
relationship-building, and capacity-building.

The estimated total amount of noncompetitive continuation
funding in future funding years is as follows:

The estimated future year range of awards is as follows:
FY 2013 up to $3,000,000); FY 2014 (up to $3,000,000); FY 2015 (up to $3,000,000).
The maximum size award in future year funding will not exceed $3,000,000 per
award in total (direct plus indirect) costs in FY 2013, FY 2014, and FY
2015. The length of support will depend on the nature of the project. The
budget period in future funding years will be for project implementation as
follows: FY 2013 (12 months), FY 2014 (12 months), and FY 2015 (12
months).

Program funds may not be used for any purpose other than
those related to the regulation of tobacco products under the Tobacco Control
Act. These funds may not be used towards tobacco control compliance and
enforcement efforts. Program funds may not duplicate or supplant existing
tobacco control, prevention, or cessation efforts, but can enhance existing
efforts relevant to FDA/CTP and the Tobacco Control Act. In addition,
funds may not be used to finance other tobacco control areas such as
surveillance, price and tax measures, clean indoor air laws, tobacco control
compliance and enforcement efforts, and treatment services like quit lines,
nicotine replacement therapy, or any other pharmaceutical or biomedical
therapy.

Throughout the project period, FDA/CTP’s commitment to
continuation of awards will be conditioned on the availability of funds,
evidence of satisfactory performance and outcomes by the recipient (as
documented in required reports and site visit observations), and the
determination that continued funding is in the best interest of the Federal
Government.

Funds should be requested for travel to the metropolitan Washington, D.C. area for annual and episodic meetings with program staff (applicants
should budget for three meetings per year for principal grantee staff).

In addition, if the cooperative agreement is awarded,
funding recipients will be informed if any additional documentation is needed
to support their award. The program office will have continuous interaction
with the recipient through site visits, collection of progress reports, and
provision of training and technical assistance. There may be other meetings
with funding recipients to assist in fulfilling the requirements of the
cooperative agreement.

Award Project Period

Maximum project period is four (4) years.

Future year amounts depend on annual appropriations and
performance.

FDA grants policies as
described in the HHS Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

CTP’s cooperative agreement program is meant to foster
partnerships between governmental agencies and community-based organizations to
promote the public's health by educating Americans about the goals of FDA
tobacco product regulation and the risks of tobacco use. These efforts are
rooted in the Tobacco Control Act and in regulatory activities that CTP has
conducted and will conduct. To best accomplish this goal, non-profit
organizations (other than institutions of higher education), governmental
agencies, and faith-based or community-based organizations are uniquely
positioned to engage partners and build coalitions in unique, efficient and
highly effective ways and have the experience to implement evidence-based
tobacco prevention and cessation programs aimed at reaching vulnerable target populations.
Higher education organizations will have the opportunity to participate in this
program as sub-awardees. A community-based organization is defined as a public
or private nonprofit organization of demonstrated effectiveness that:

(1) Is representative of a community or significant segments
of a community; and

(2) Provides educational or related services to individuals
in the community.

This cooperative agreement program is only available to
eligible organizations who demonstrate collaboration between at least one
governmental agency and at least one community-based organization. If a lead
applicant is a government agency, it must partner with at least one
community-based organization. If a lead applicant is a community-based
organization, it must partner with a governmental agency. The following
organizations/entities are eligible to apply:

This cooperative agreement program is not available to any
organization if it or any of its officers or employees, partners, affiliates,
agents, contractors, or subcontractors maintains any of the following financial
interests or business arrangements: (a) provides consulting services or other
contractual services to a tobacco product manufacturer, distributor, or
retailer, as those terms are defined by the Tobacco Control Act (hereinafter
"tobacco entity"; (b) serves as an expert witness on behalf of a
tobacco entity; (c) conducts research sponsored by or directed by a tobacco
entity (either directly or indirectly); (d) sits on a corporate board or advisory
board of a tobacco entity; (e) lobbies or testifies on regulatory or
legislative matters on behalf of a tobacco entity; (f) names any building,
program, or project after a tobacco entity, a tobacco brand, or a tobacco
entity employee; or (g) receives funds from a tobacco entity. The above does
not apply where an organization receives funds from a tobacco entity pursuant
to a court order or statutory directive and the tobacco entity does not retain
any control over the use of such funds.

If awarded a cooperative agreement, the organization and its
officers and employees, as well as its partners, affiliates, agents,
contractors and subcontractors must refrain from engaging in any of the
activities listed in (a) - (g) above during the course of the cooperative agreement
program. By submitting an application, applicants affirm that they meet the
eligibility requirements described in this section.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

eRA Commons is the infrastructure utilized by FDA for
conducting interactive electronic transactions for the receipt, review,
monitoring, and administration of grant awards. All Program
Directors/Principal Investigators (PD/PIs) must also work with their
institutional officials to register with the eRA Commons or ensure their
existing eRA Commons account is affiliated with the eRA Commons account of the
applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for FDA support.

Applicant organizations may submit more than one application,
provided that each application is programmatically distinct.

FDA will not accept any application in response to this FOA
that is essentially the same as one currently pending review unless the
applicant withdraws the pending application. FDA will not accept any
application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows FDA/CTP staff to estimate the potential review workload
and plan the review.

By the date listed in Part 1. Overview Information,
prospective applicants are asked to submit a letter of intent that includes the
following information:

1. Descriptive title of proposed public
education/communication program
2. Name, address, and telephone number of the applicant
3. Number and title of this funding opportunity

The letter of intent should be sent via electronic mail as a
Word or PDF file to CTP-OHCE_CoAg@fda.hhs.gov with “Cooperative Agreement Letter of Intent” in the message subject heading.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Page
Limitations

All page
limitations described in the SF424 Application Guide must be followed, with the
following exceptions or additional requirements:

For this specific FOA, the Project Strategy section (referred to
as the Research Strategy section on the SF 424 (R&R) is limited to 25 pages.

Responsiveness

To be responsive, an application must be submitted in
accordance with the requirements of this notice, including:

1) The application must request support at or below the
maximum amount allowable;

2) The application must be from an eligible organization;

3) The application must contain a memorandum of
understanding or equivalent between the eligible applicant, the governmental
agency, community-based organization, and other key partners; and

4) The application must propose activities that establish or
expand health communication and education programs at the community level that are
related to the regulation of tobacco products under the Tobacco Control Act.

Applications found to be non-responsive will receive notice
that the application will not be reviewed.

Application
Components

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow all instructions in the SF424 (R&R) Application
Guide to ensure you complete all appropriate “optional” components.

Proof of nonprofit status must be submitted by private
nonprofit organizations with the application. Any of the following is
acceptable evidence of nonprofit status: (a) a reference to the applicant
organization's listing in the Internal Revenue Service's (IRS) most recent list
of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b)
a copy of a currently valid IRS tax exemption certificate; (c) a statement from
a State taxing body, State Attorney General, or other appropriate State
Official certifying that the applicant organization has a nonprofit status and
that none of the net earnings accrue to any private shareholders or
individuals; (d) a certified copy of the organization's certificate of
incorporation or similar document that clearly establishes nonprofit status;
(e) any of the above proof for a State or national parent organization and a
statement signed by the parent organization that the applicant organization is
a local nonprofit affiliate.

A complete application consists of the following components:

SF 424 Cover Component

SF 424 R&R Project/Performance Site Locations Component

SF 424 Other Project Information Component

Project Abstract

Project Strategy (referred to as the Research Strategy on
the SF 424 (R&R)

Bibliography

Memorandum of Understanding or Equivalent

SF 424 Senior/Key Person Profile Expanded Component

Resumes of Key Personnel and/or position descriptions

R&R Budget Component

Budget Justification

Required Forms

Standard Forms, and

Assurances and Certifications

Standard Form LLL, Disclosure of Lobbying Activities

Instructions
for Project Summary/Abstract

Include the following information in
your abstract:

A list of partner entities that will assist you in coordinating
or providing services;

A description of the target population/audience to be served;

Identification of the CTP public health regulatory topic(s) to be
addressed; and

A brief summary of the activities and novel approaches that would
be implemented.

The abstract narrative should not exceed one page and should
use language that will be understood by a range of audiences.

The Project Abstract should be attached to the SF 424
(R&R) Other Project Information Component

Instructions
for Project
Strategy (referred to as the Research Strategy on the SF 424 R&R)

The Project Strategy (referred to as the Research Strategy
on the SF 424 R&R) is where applicants attach their narrative responses to
the selection criteria and requirements published in this FOA. Note that
applications will be reviewed according to the specific selection criteria and
the requirements specified in this FOA.

Please limit the Project Strategy to 25 pages,
double-spaced, and number the pages consecutively. Please provide any charts,
graphs, citations, or examples in the project strategy. Refer to Section
IV—Application and Submission Information of the FOA for additional application
submission requirements and Section I—Funding Opportunity Description for
detailed information regarding the requirements for the Tobacco Regulation
Awareness, Communication, and Education Program competition. Applicants must
implement a comprehensive public education and/or communication program that relates
to federal tobacco regulation and the public health goals that underlie that regulation,
as identified in the applicant’s needs assessment and that will improve health
outcomes for members of target population(s). Applicants must demonstrate how
proposed activities are related to CTP’s public health regulatory activities under
the Tobacco Control Act.

The Project Strategy should be attached to the SF 424
(R&R) Other Project Information Component.

Instructions
for Bibliography

Provide a bibliography of any references cited in the Project
Strategy. Each reference must include the names of all authors (in the same
sequence in which they appear in the publication), the article and journal
title, book title, volume number, page numbers, and year of publication.
Include only bibliographic citations.

The Bibliography should be attached to the SF 424 (R&R)
Other Project Information Component.

Instructions
for the Memorandum of Understanding

A Memorandum of Understanding (MOU) or equivalent between
the eligible organization, the government agency, at least one community-based
organization, and key partners must be included in the application submission.
Key partners should work together based on identified needs and with clearly
articulated and mutually defined goals, target populations, roles, and desired
results and outcomes. The MOU or equivalent should describe the role each
partner will assume, the services or resources each will provide, and the
desired results and outcomes.

Instructions
for Budget Justification

Before preparing the budget justification narrative,
applicants should review the FOA.

Provide a detailed budget breakdown for each budget category
listed in the SF 424 (R&R) Budget Component form. If funds are being
requested for more than one budget period, you must complete a separate
detailed budget for each year of support requested. Funds may be requested as
long as the item and amount are necessary to perform the proposed work and are
not precluded by the cost principles or program funding restrictions. Provide
other budget explanations or comments deemed necessary.

The budget justification should be attached to the SF 424
(R&R) Budget Component.

When multiple institutions are involved, one institution
must be designated as the lead institution/fiscal agent and funding for other
institution(s) must be requested via a subcontract to be administered by the
lead institution. When submitting a detailed budget, the lead institution
should submit its budget using the SF 424 (R&R) Budget Component. All
other institutions should have their individual budgets attached separately to
the SF 424 (R&R) Sub award Budget Attachments Form. See Section 4.8 of the
SF 424 (R&R) Application Guide for further instruction regarding the use of
the sub award budget form.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

All FDA awards are subject to the terms and conditions, cost
principles, and other considerations described in the HHS Grants
Policy Statement.

Pre-award costs are not allowable.

Program funds may not be used for any purpose other than those
related to the regulation of tobacco products under the Tobacco Control Act, as
described in this notice. These funds may not duplicate or supplant existing
tobacco control, prevention, or cessation efforts, but can enhance existing
efforts relevant to FDA/CTP and the Tobacco Control Act. In addition,
grant funds may not be used to finance other tobacco control areas such as
surveillance, price and tax measures, clean indoor air laws, tobacco control
compliance and enforcement efforts, and treatment access like quit lines,
nicotine replacement therapy, or any other pharmaceutical or biomedical therapy.

Applicants should be aware of restrictions on the use of HHS
funds for lobbying of Federal or State legislative bodies. Under the provisions
of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are
prohibited from using appropriated Federal funds (other than profits from a
Federal contract) for lobbying congress or any Federal agency in connection
with the award of a particular contract, grant, cooperative agreement, or loan.

Applicants for (and recipients of) Federal grants,
cooperative agreements, contracts, and loans are prohibited by 31 U.S.C. 1352,
“Limitation on use of appropriated funds to influence certain Federal
contracting and financial transactions,” from using appropriated Federal funds
to pay any person for influencing or attempting to influence any officer or
employee of an agency, a member of Congress, an officer or employee of
Congress, or an employee of a member of Congress with respect to the award,
extension, continuation, renewal, amendment, or modification of any of these
instruments. These requirements are implemented for HHS in 45 CFR Part 93,
which also describes types of activities, such as legislative liaison
activities and professional and technical services that are not subject to this
prohibition. The provisions are not intended to prohibit all interaction with
the legislative branch, or to prohibit educational efforts pertaining to public
health. Clearly there are circumstances when it is advisable and permissible to
provide information to the legislative branch in order to foster implementation
of prevention strategies to promote public health. However, it would not be
permissible to influence, directly or indirectly, a specific piece of pending legislation

Applicants for HHS grants with total costs expected to
exceed $100,000 are required to certify that they have not made, and will not
make, such a prohibited payment; will be responsible for reporting the use of
non-appropriated funds for such purposes; and will include these requirements
in consortium agreements, other sub-awards, and contracts under grants that
will exceed $100,000 and will obtain necessary certifications from those
consortium participants and contractors.

6. Other Submission Requirements
and Information

Applications must be submitted electronically following the
instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the assigned Grants Management Specialist and responsiveness by
a member of the Center for Tobacco Products' staff. Applications that are
incomplete and/or nonresponsive will not be forwarded for review..

Section V. Application Review Information

1. Criteria

Only responsive applications will be considered in the
review process using the review criteria described below.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the topic area(s) involved, in consideration
of the following review criteria (as applicable for the project proposed).

Scored Review Criteria

All applications will undergo an objective review process
and will be evaluated individually for strengths and weaknesses against the
criteria that follow, respectively. Each proposal will be evaluated
and scored in relation to the selection criteria.

Need
and Significance of the Project (25 points)

What is the magnitude or severity of the problems to
be addressed by the proposed project in relation to indicators of need and
target population to be served? What is the extent to which the proposed
project will identify and address specific gaps or weaknesses in services,
infrastructure, or opportunities? What is the likelihood and extent to which
the proposed project will increase capacity at the community level in the areas
of health communication and education? What is the extent to which the proposed
project involves the development or demonstration of promising or innovative
strategies that build on, or are alternatives to, existing strategies? What is
the potential to sustain and apply the model of the proposed project or
strategies, including, as appropriate, the potential for implementation of the
model in a variety of settings?

Quality
of the Project Design (30 points)

Has the applicant provided a detailed implementation
plan that addresses the goals, objectives, action steps, timeline with
milestones, and description of the role of key partners? Does the applicant
describe strategies that are based on the best available evidence? Does the
plan include strategies that will lead to significant improvements in promoting
the understanding of tobacco product contents and the consequences of tobacco
use; protecting youth from the dangers of tobacco use; and/or increase
cessation among those who use tobacco? How will the applicant use data to
manage program implementation, inform decision-making, engage stakeholders, and
measure success? Has the applicant provided an evaluation plan that aligns with
project goals, objectives, activities, and performance measures? Does the
applicant demonstrate an ability to customize and tailor tools and resources to
the local level? What is the extent to which the proposed project will be
coordinated with similar or related efforts, and with other appropriate
community, State, and Federal resources?

Management
Plan (25 points)

Is the management plan adequate to achieve the
objectives of the proposed project on time and within budget, including clearly
defined responsibilities, timelines, and milestones for accomplishing project
tasks? Have MOU’s or equivalent been included for key partners that describe
each partner’s financial and/or programmatic commitment; how each partner’s
existing vision and existing activities align with those of the proposed
project? What is the governance structure of the proposed project? How
extensive is the expertise and experience of the applicant institution and
their key personnel in coordinating collaborative endeavors of the size, scope
and scientific complexity needed for this Program? Does the organization have
experience building coalitions between governmental and community based
entities? What is the potential for continued support of the project after
Federal funding ends, including, as appropriate, the demonstrated commitment of
appropriate entities to sustain and “scale up” the proposed project?

Key
Personnel (20 points)

What is the background, expertise, and administrative
experience of key project staff who will direct, manage, and administer the
program and/or identify key hires that will be necessary to carry out the
program and is it appropriate? Do key staff have documented success with a
similar program? Does the applicant demonstrate leadership and extensive
experience working on complex tobacco prevention and counter-marketing
campaigns and initiatives for a governmental entity or a public health
organization? Are proposed program staff able to collaborate effectively
within his/her own organization and with individuals at collaborating
organizations? Does the applicant adequately describe the role of all proposed
staff and the processes for ensuring that staff meets program and role
expectations? Please note: if awarded, all changes in key program personnel
will require prior approval from FDA/CTP.

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Not applicable.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed project.

2. Review and Selection
Process

All applications will undergo an objective review process.
An objective review panel will evaluate complete and responsive applications
according to the criteria listed in the “Objective Review Criteria” section
above. The panel will be comprised of FDA, HHS, and/or other Federal program
officials outside of the program office (CTP Office of Health Communication and
Education) and will be scored using the pre-determined weight criteria listed
in the “Application Review Information” section above. Funding decisions
will be made by the Commissioner of Food and Drugs or her designee.

Funding decisions may also be made to ensure:

1) Adequate representation of activities related to the
regulation of tobacco products under the Tobacco Control Act, including a
variety of public education and/or communication programs/campaigns and
evidence-based communications strategies.

As set forth in Section III.1, certain financial interests
and business relationships render an applicant ineligible. For eligible
applicants that undergo objective review, funding decisions will consider,
among other things, whether there are other financial interests or business
arrangements with third parties (to include contracts, subcontracts, and
grants) that would call into question the ability or motivation of the
applicant to objectively and effectively carry out the proposed project. The
Grants Management Specialist may request additional financial information to
aid in the evaluation of financial interests and/or business relationships
prior to award decision. Applicants with any financial interests or business
arrangements that might call into question the ability or motivation of the
applicant to effectively carry out the proposed project should (1) disclose the
interest or business arrangement; (2) describe how the interest or business
arrangement could actually, or be perceived to, impair the applicant’s ability
or motivation to effectively carry out the proposed project; and (3) set forth
any steps, plans, or procedures the applicant will take to mitigate the effect
of the interest or arrangement on the ability to effectively carry out the
proposed project.

The request for and subsequent submission of financial
information or mitigation plans does not imply an award decision.

If the application is under consideration for funding, FDA may
request "just-in-time" information from the applicant to reach a
final award decision.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.4. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs. Pre-award costs are
not allowable for this opportunity.

Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for HHS Grants recipients.

2. Administrative and
National Policy Requirements

All FDA grant and cooperative agreement awards will be
subject to all policies and requirements that govern the programs of FDA,
including provisions of 42 CFR Part 52 45 CFR Parts 74 and 92, and theHHS Grants
Policy Statement.

Applicants must adhere to the requirements of this notice.
Special terms and conditions regarding FDA regulatory requirements and adequate
progress of the project may be part of the awards notice.

The following terms and conditions will be incorporated into
the award statement and will be provided to the Project Director/Principal
Investigator as well as the appropriate institutional official at the time of
the award.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services grant
administration regulations at 45 CFR parts 74 and 92 and other HHS, PHS, and
the FDA grant administration policies.

The administrative and funding instrument used for this
program will be the cooperative agreement, an "assistance" mechanism,
in which substantial FDA programmatic involvement with the awardees is
anticipated during the performance of the activities. Under the cooperative
agreement, the FDA purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a collaborative role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the FDA as defined below.

The Project Director/Principal Investigator (PD/PI) retains
the primary responsibility and dominant role for planning, directing, and
executing the proposed project, with FDA/CTP staff being substantially involved
as a partner with the PD/PI, as described below.

The PD/PI will maintain general oversight for ensuring
compliance with the financial and administrative aspects of the award, as well
as ensuring that all staff have sufficient clearance and/or background checks
to work on this project. This individual will work closely with designated
officials within the recipient organization and with partner organizations to
create and maintain necessary documentation, including both technical and
administrative reports; prepare justifications; appropriately acknowledge
Federal support in publications, announcements, news programs, and other media;
and ensure compliance with other Federal, regulatory, and organizational
requirements.

2. A.2. FDA Responsibilities

An FDA Project Officer (PO) is the official responsible for the programmatic,
scientific, and/or technical aspects of assigned applications and cooperative
agreements.

The FDA PO will have substantial programmatic involvement
that is above and beyond the normal stewardship role in awards as described
below. The PO will have substantial involvement in the design, implementation,
and evaluation of program activities, and dissemination of program results and
outcomes, above and beyond routine grant monitoring. Substantial involvement
by FDA/CTP includes, but is not limited to, the following:

6.
Identify and disseminate results of promising and effective health
education and communication programs and practices.

7.
Provide communication tools, as developed, for potential use in program
efforts. These tools could include research, strategies, creative assets and
materials, and media buys.

8.
Provide final approval of campaign materials and strategies prior to
dissemination.

Monitoring
Activities

The program project officer will monitor grantees
periodically. The monitoring may be in the form of telephone conversations,
e-mails, or written correspondence between the project office/grants management
office and the principal investigator. Periodic site visits with officials of
the funding recipient organization may also occur. The results of these
monitoring activities will be recorded in the official grant file and will be
available to the funding recipient upon request consistent with applicable
disclosure statutes and with FDA disclosure regulations. Also, the grantee
organization must comply with all special terms and conditions of the cooperative
agreement, including those which state that future funding of the project will
depend on recommendations from the project officer. The scope of the
recommendation will confirm that: (1) there has been acceptable progress on the
project; (2) there is continued compliance with all FDA regulatory
requirements; (3) if necessary, there is an indication that corrective action
has taken place; and (4) assurance that any replacement of personnel will meet
the prior approval of the FDA/CTP program office and grants management officer.

3. Reporting

For continuing cooperative agreements, an annual program
progress report is required. Awardees will be required to submit annual
performance reports and financial status reports as required in the HHS Grants
Policy Statement.

A final program progress report must be submitted within 90
days after the expiration of the project period as noted on the Notice of Grant
Award. A final progress report is also required when an award is
relinquished, when a recipient changes institutions, or when an award is
terminated. The final program progress report must provide full written documentation
of the project, and summaries of achievement of project goals, objectives, and
performance measures as described in the grant application.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier sub awards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable FDA grants and cooperative agreements are required to report to
the Federal Sub award Reporting System (FSRS) available at www.fsrs.gov on all sub awards over $25,000.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Pre-Application
Meeting

FDA/CTP will hold a pre-application meeting for prospective
applicants on April 5, 2012 from 1:00 p.m. to 2:30 p.m. (EST) via webinar.
Interested parties are invited to participate in this meeting to discuss the
purpose of the Program, application requirements, selection criteria,
application content, submission requirements, and reporting requirements.
Interested parties may participate in this meeting either by conference call or
via the World Wide Web.

Individuals interested in attending this meeting should
register via electronic mail no later than March 30, 2012 with the following
information: participant name, organization, and contact information with
“PRE-APPLICATION MEETING” in the subject line to CTP-OHCE_CoAg@fda.hhs.gov. There
is no registration fee for participating in this meeting. For further
information contact Tracy Galloway, Center for Tobacco Products, U.S. Food and
Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20850. E-mail: CTP-OHCE_CoAg@fda.hhs.gov.

All awards will be subject to all policies and requirements
that govern discretionary grant programs of the PHS as incorporated in the U.S.
Department of Health and Human Services (HHS) Grants Policy Statement dated
January 1, 2007 (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf),
including the provisions in 45 CFR Parts 74 and 92. The regulations issued
under Executive Order 12372 do not apply to this program.

All electronic media produced under the terms of resulting
grant agreements funded by CTP must be must be Section 508 compliant. For more
information about Section 508 compliant communications visit www.section508.gov.
Applicants should also refer to The Guide to the Section 508 Standard for
Electronic and information Technology, which is available at http://www.access-board.gov/sec508/guide/index.htm.

Consistent with the property management requirements of 45
CFR Parts 74.36 and 92.34, FDA/CTP reserves a royalty-free, nonexclusive, and
irrevocable right to reproduce, publish, or otherwise use work that was
developed for Federal purposes, and to authorize others to do so.

Required
Federal Regulations

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals
involving human subjects must be evaluated with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Access to Research Data through the Freedom of Information
Act (FOIA) (NIH Policy Adopted by the FDA):

The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are: (1) first produced in a project that
is supported in whole or in part with Federal funds; and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment.
NIH/DHHS has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should think about how to structure informed consent statements and
other human subjects procedures given the potential for wider use of data
collected under this award.

Required Education on the Protection of Human Subject
Participants (NIH Policy Adopted by the FDA)

The Department of Health and Human Services (HHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health
Information," the "Privacy Rule," on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

Sharing Research Data (NIH Policy Adopted by the FDA)

Investigators submitting an application to the FDA seeking $500,000 or more in
direct costs in any single year (if applicable) are expected to include a plan
for data sharing or state why this is not possible (see http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions on issues related to
institutional policies and local institutional review board (IRB) rules as well
as local, State and Federal laws and regulations, including the Privacy Rule.

Healthy People 2020

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2020," a PHS-led
national activity for setting priority areas. This FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2020" at http://www.health.gov/healthypeople.

Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Section 301 of the Public Health Service Act as
amended (42 USC 241), Section 312 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (42 USC 247b-20), and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards
are subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants
Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92